Disinfecting luer cap and method of use

ABSTRACT

Medical devices including a cap for a medical connector are disclosed. In some embodiments, the cap comprises a disinfectant, such as an antiseptic fluid and an insert configured to seal or partially seal the medical connector as it is engaged with the cap. In some embodiments the cap insert has a segment which is deformable under axially applied pressure as an end-user attaches the cap to the medical connector. In some embodiments this insert is configured to improve the exposure of antiseptic to the outer surface of the medical connector while minimizing exposure of the antiseptic inside the medical connector open lumen.

RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No.62/560,808, filed on Sep. 20, 2017 and titled, “Disinfecting Luer Capand Method of Use,” and U.S. Provisional Application No. 62/451,298,filed on Jan. 27, 2017 and titled, “Disinfecting Caps for Open LuerConnectors,” both of which are hereby incorporated by reference in theirentireties.

TECHNICAL FIELD

The field of the present disclosure relates generally to medicaldevices. More specifically, the present disclosure relates to caps formedical connectors. In some embodiments, the present disclosure relatesto caps that can be used to protect the sterility of open medicalconnectors.

BRIEF DESCRIPTION OF THE DRAWINGS

The embodiments disclosed herein will become more fully apparent fromthe following description and appended claims, taken in conjunction withthe accompanying drawings. The drawings depict only typical embodiments,which embodiments will be described with additional specificity anddetail in connection with the drawings in which:

FIG. 1 depicts a simplified exploded view of certain components of amedical connector cap.

FIG. 2A depicts a simplified end view of certain components of a medicalconnector cap.

FIG. 2B depicts a simplified cross-section view of certain components ofthe medical connector cap of FIG. 2A, taken through plane A-A.

FIG. 3A depicts a simplified perspective view of a medical connector.

FIG. 3B depicts a simplified perspective view of another embodiment of amedical connector.

FIG. 4A depicts a simplified cross-section view of certain components ofa medical connector cap engaging with certain components of a medicalconnector, in a first configuration.

FIG. 4B depicts a simplified cross-section view of certain components ofthe medical connector cap and medical connector of FIG. 4A in a secondconfiguration.

FIG. 5 depicts a simplified side view of a portion of a medicalconnector cap.

FIG. 6 depicts a simplified side view of a portion of another embodimentof a medical connector cap.

FIG. 7 depicts a simplified perspective view of a portion of anotherembodiment of a medical connector cap.

FIG. 8A depicts a simplified exploded view of certain components of amedical connector cap.

FIG. 8B depicts a simplified side view of certain components of amedical connector cap.

FIG. 8C depicts a simplified cross-section view of certain components ofthe medical connector cap of FIG. 8B taken through plane 8C.

FIG. 9A depicts a simplified cross-section view of certain components ofa female luer connector.

FIG. 9B depicts a simplified cross-section view of certain components ofa medical connector cap engaged with a female luer connector.

FIG. 9C depicts a simplified cross-section view of certain components ofa female luer connector.

DETAILED DESCRIPTION

Patients undergoing various treatments may receive a central vascularcatheter. Exposure of such catheters to foreign bodies increases therisk of catheter-related bloodstream infections. Infections associatedwith central venous catheters are categorized as either central-lineassociated bloodstream infections or catheter-related bloodstreaminfections. These infections can increase hospital costs and length ofstay. The costs to hospitals and the health care system from theseinfections are substantial in terms of both morbidity and resourcesexpended.

In the detailed description, reference is made to the accompanyingdrawings which form a part hereof and in which are shown, by way ofillustration, specific embodiments of the disclosure. These embodimentsare described in sufficient detail to enable those of ordinary skill inthe art having the benefit of this disclosure to practice the presentdisclosure, and it is to be understood that other embodiments may beutilized, and that structural, logical, and electrical changes may bemade within the scope of the disclosure. From the followingdescriptions, it should be understood that components of the embodimentsas generally described and illustrated in the figures herein could bearranged and designed in a wide variety of different configurations.Thus, the following more detailed description of various embodiments, asrepresented in the figures, is not intended to limit the scope of thedisclosure, but is merely representative of various embodiments. Whilethe various aspects of the embodiments are presented in drawings, thedrawings are not necessarily drawn to scale unless specificallyindicated.

In this description, specific implementations are shown and describedonly as examples and should not be construed as the only way toimplement the present disclosure unless specified otherwise herein. Itwill be readily apparent to one of ordinary skill in the art having thebenefit of this disclosure, for example, that the various embodiments ofthe present disclosure may be practiced with numerous types and forms ofmedical connectors. The devices and methods described herein could beuseful in a number of environments that employ conduits or connectors,for example, the present disclosure may be practiced in any situationthat uses at least one connector with a luer end.

It should be understood that any reference to an element herein using adesignation such as “first,” “second,” and so forth does not limit thequantity or order of those elements, unless such limitation isexplicitly stated. Rather, these designations may be used herein as aconvenient method of distinguishing between two or more elements orinstances of an element. Thus, a reference to first and second elementsdoes not mean that only two elements may be employed there or that thefirst element must precede the second element in some manner. Also,unless stated otherwise a set of elements may comprise one or moreelements.

The phrases “connected to” and “coupled to” refer to any form ofinteraction between two or more entities, including mechanical,electrical, magnetic, electromagnetic, fluid, and thermal interaction.Two components may be connected or coupled to each other even thoughthey are not in direct contact with each other. For example, twocomponents may be coupled to each other through an intermediatecomponent.

The directional terms “proximal” and “distal” are used herein to referto opposite locations on a medical device. The proximal end of thedevice is defined as the end of the device closest to the end-user whenthe device is in use by the end-user. The distal end is the end oppositethe proximal end, along the longitudinal direction of the device, or theend furthest from the end-user.

Referring in general to the following description and accompanyingdrawings, various embodiments of the present disclosure are illustratedto show its structure and method of operation. Common elements of theillustrated embodiments may be designated with similar referencenumerals. Accordingly, the relevant descriptions of such features applyequally to the features and related components among all the drawings.Any suitable combination of the features, and variations of the same,described with components illustrated in FIG. 1, can be employed withthe components of FIG. 2, and vice versa. This pattern of disclosureapplies equally to further embodiments depicted in subsequent figuresand described hereinafter. The figures presented are not meant to beillustrative of actual views of any particular portion of the actualstructure or method, but are merely idealized representations employedto more clearly and fully depict the present disclosure defined by theclaims below.

One embodiment of the present disclosure comprises a cap for a medicalconnector. The medical connector may have a luer connector. The cap mayfurther comprise a disinfecting agent. In some embodiments the capcomprises a chamber containing the disinfecting agent. When an end-userattaches the cap comprising the disinfecting agent to the luer connectorit applies the disinfectant to the open end of the luer connector. Theopen end of the cap is configured to connect to a medical connector suchas a luer connector. In some embodiments the cap is configured to engagewith a female luer connector, and in other embodiments the cap isconfigured to a male luer connector. For example, the cap may beconfigured with threads to engage a medical connector such as a male orfemale luer connector. In some embodiments these threads are configuredwith a hard stop to prevent an end-user from over rotating the cap.Additionally or alternatively, the threads may be configured to providesufficient rotation of the cap with respect to a connector to dispensean adequate amount of antiseptic fluid to provide effectivedisinfection.

The cap may comprise a chamber which has a chamber inner lumen. Withinthe cap chamber the cap may further comprise a reservoir and an insert.The insert is disposed in the chamber lumen and comprises a first endwhich is shaped to engage with the open end of a medical connector suchas a luer connector. This shape may be dome shaped, a frusto-conicalshape, or any other shape which may seal or partially seal the open endof a medical connector to reduce fluid entering the lumen of the medicalconnector while maximizing the flow of fluid around the insert and theouter surfaces of the medical connector.

In some embodiments the cap is configured to facilitate alignment of theinsert with the open end of a medical connector. For example, the insertmay be disposed within the cap such that threads of the cap tend toalign the insert and a medical connector during coupling of the cap andmedical connector. The insert may thus tend to engage flush with theopen end of a luer connector. In some embodiments the insert may engagesubstantially perpendicular to the open end of the luer so that theentire circumference of the open end of the luer connector engagessubstantially simultaneously with the insert. Engaging substantiallysimultaneously around the entire circumference of the open end of theluer connector may, in turn, reduce or minimize an antiseptic fluid fromflowing into the inner luminal space of the luer connector when itengages with the cap.

The insert may also comprise an annular gap that allows an antisepticfluid to flow around the insert and interact with the surface of thedome shaped first end of the insert during coupling of a cap and amedical connector. As the cap engages with the medical connector radialexpansion of the insert may tend to reduce or eliminates this gapreducing or eliminating the amount of antiseptic fluid which can flowaround the insert and interact with the medical connector.

Some caps within the scope of this disclosure may be configured to hold45 pounds per square inch (PSI) of pressure.

The insert may further comprise a second end which is configured todeform when an end-user, such as a health care worker, engages the caponto a medical connector. As the medical connector, such as the luerconnector, is engaged with the cap the open end of the luer connectorexerts axial force against the insert. In some embodiments, the insertsecond end deforms radially as the insert moves axially. The inner wallsof the cap chamber may limit the degree the insert second end is able todeform under this axial force. In some embodiments, when the end-userdisengages the cap from the luer connector, the insert second end beginsto assume its original shape. In this way the insert may move like aspring axially within the cap chamber. When the insert springs back intoits original shape it may thus maintain an axial force against the luerconnector open end until the luer connector fully disengages from thecap. As the cap is disengaged in this manner the seal or partial seal ismaintained between the insert first end and the open end of the luerconnector, minimizing the amount of fluid that is able to enter the openend of the luer connector. This second end of the insert may be thoughtof as a controlled-deformation segment and serves to provide axial forceagainst the medical connector which has been engaged with the cap. Insome embodiments the insert second end may comprise external ribs thatcontact protrusions on the internal sidewall of the cap chamber. The capis reusable, for example, configured with an insert that is able todeform and spring back into its original shape multiple times, or thecap may be configured as a single use device. The cap second end isfurther configured to be grasped comfortably and securely by anend-user, such as a health care worker.

In some embodiments the cap chamber further comprises a reservoirconfigured to absorb fluid, such as disinfectant antiseptic fluid. Insome embodiments the reservoir is polyester urethane foam. In someembodiments the polyester urethane foam has a density of between 0.5 and4 lbs/ft3. In some embodiments the polyester urethane foam has a densityof between 1 and 3 lbs/ft3. In some embodiments the polyester urethanefoam has a density of 2 lbs/ft3. In some embodiments the reservoirsurrounds the insert. In alternative embodiments the reservoir is in ahollow portion of the insert. In some embodiments the reservoir isaxially distal to the insert, in other words further from the open capfirst end. In some embodiments the reservoir is axially proximal to theinsert, in other words closer to the open cap first end. In someembodiments the reservoir is in contact with the insert first end. Insome embodiments the reservoir is in contact with the insert second end.

Various materials are within the scope of this disclosure. For example,the insert may be comprised of various polymeric and/or elastomericmaterials, including silicones, isoprene, neoprene, Santoprene, and soforth. The reservoir may comprise various foam materials, includingpolyester urethane foam as discussed above. The reservoir may alsocomprise an elastomeric material, including elastomers including poresor other structures capable of absorbing a liquid antiseptic agent. Thereservoir may be a non-particulate elastomer configured to reduce orminimize breakdown of the reservoir that may result in particles withinthe cap or connector. Embodiments wherein the insert comprises a hollowportion or void with no separate component was a reservoir (such asembodiments wherein a void within an elastomeric insert is configured toact as a reservoir for an antiseptic fluid) are also within the scope ofthis disclosure.

The cap chamber may contain a disinfectant, such as an antiseptic. Insome embodiments this antiseptic may be an antiseptic fluid such asisopropyl alcohol, hydrogen peroxide, chlorhexidine gluconate, iodophor,povidone iodine, or any other suitable antiseptic. In some embodimentsthe antiseptic is not fluid but in the form of disinfectant beads, suchas hydrogel beads, disinfectant foam, or a loaded polymer. In someembodiments the antiseptic is sequestered in the cap chamber within afirst closed compartment by a breakable seal, such as a foil seal. Thisfoil seal will stay intact until an end-user engages the cap with amedical connector which then may exert axial pressure on the cap insert.Alternatively, a foil seal may be disposed across the cap chamber suchthat an end-user can peel off or otherwise remove the foil seal prior touse. The cap insert may then deform, exerting radial force which canthen break the seal holding the antiseptic, releasing it into the capchamber. In this way, the antiseptic is released and surrounds theinsert and the outer surfaces of the medical connector while minimizingthe amount of antiseptic that enters the luer connector open end whichis loosely sealed by the cap insert first end. In some embodiments theantiseptic is soaked into the reservoir, and when the cap insert ispushed axially it compresses the reservoir, releasing the antisepticinto the chamber and similarly surrounding the insert and the outersurfaces of the medical connector. In some embodiments the antisepticfluid is both in an absorbent reservoir and sequestered in a breakableseal within the cap chamber inner lumen.

In some embodiments when the end-user disengages the cap from themedical connector, the insert returns to its original shape, whichincreases the volume within the cap chamber. As the insert returns toits original shape the reservoir will expand, increasing the volume offluid, such as antiseptic fluid, the reservoir can hold. As thereservoir expands it creates a vacuum or partial vacuum acting on thefluid, thus tending to draw in and absorb the fluid which had beensurrounding the insert and the outer surfaces of the medical connector.In this way as the cap is disengaged from the medical connector theamount of fluid in contact with the outer surface of the medicalconnector decreases, which serves to further reduce the amount of fluidthat enters the open end of the medical connector as it is fullydisengaged from the cap and the insert first end.

In some embodiments the cap insert may be configured to store theantiseptic within the insert. For example, the insert may be hollow withside apertures to permit the antiseptic agent to flow out of the insertwhen axial force is exerted on the insert from the end-user attaching amedical connector to the cap. In some embodiments the insert first endmay inhibit flow of fluid, such as an antiseptic fluid into the lumen ofan engaged medical connector while allowing flow to specific regions onor in the medical connector. In some embodiments the insert is made of asingle material. In alternative embodiments the insert first end is madeof material different from the insert second end. In some embodimentsthe insert first end is reinforced to reduce deformation when axialforce is applied to the insert when an end-user attaches a medicalconnector to the cap. In some embodiments the cap is configured withradial protrusions to maintain the insert in the cap chamber.

In some embodiments the method of capping a medical connector with acap, as described above, is disclosed herein. The end-user may obtain acap, as described above. If a foil seal is present, the end-user maypeels off a foil seal from an end of the cap to open the cap chamber.The end-user may then connect the cap to the open end of the medicalconnect and twist either the cap to fully engage the cap on theconnector or the connector to fully engage the cap. The cap will thendisinfect, as described above, the outer surface of the medicalconnector while minimizing the amount of disinfectant that enters theopen end of the medical connector. In some embodiments the cap may beconfigured with threading to engage the medical connector. In someembodiments these threads, or an end of these threads, are configuredwith a hard stop to prevent the end-user from over rotating the cap onthe medical connector. In some embodiments the cap is configured toengage with a female luer connector. In alternative embodiments the capis configured to engage with a male luer connector. In some embodimentsthe end of the cap is sealed with a sterile seal which is removable bythe end-user just before it is attached to the medical connector.

In some embodiments the means for minimizing medical connectorinfections is provided by applying a cap, as described above, to amedical connector. The cap applies an antiseptic agent to a medicalconnector. In some embodiments, the cap has engagement means to attachto a male luer connector. In some embodiments, the cap comprises themeans for limiting or minimizing the flow of antiseptic in the capchamber as the end-user engages the open end of a medical connector withthe cap, while at the same time maximizing the flow of antiseptic to theouter surface of the medical connector. In some embodiments the capcomprises an insert in the chamber, the insert comprising the means toexert axial force against the open end of the medical connector as thecap is both engaged and disengaged with the medical connector. In someembodiments the cap is configured with a means of maintaining the insertin the cap chamber.

FIG. 1 depicts a simplified exploded view of various components of amedical connector cap 100. The cap 100 has a cap first end 116 whichcomprises an opening 114 and a second end 122 configured to be graspedsecurely and comfortably by an end-user. A cap body 120 is between thecap first end 116 and the second end 122. In the illustrated embodiment,the cap first end 116 is configured to be attached to a male luerconnector and further comprises ridges 118 which serve as threads toengage the male luer connector. The cap 100 comprises an insert 102 anda reservoir 112. The insert 102 comprises an insert first end 104configured to engage and seal or partially seal the open end of a maleluer connector. In some embodiments, the insert first end 104 of theinsert 102 may comprise a shape configured to seal or partially sealagainst a portion of a connector, such as a luer connector. For example,in the illustrated embodiment, the insert first end 104 of the insert102 comprises a dome or curved shape, configured to seal or partiallyseal against a luer connector. As also described above, other shapes,such as frusto-conical shapes, are within the scope of this disclosure.Further, the insert first end 104 of the insert 102 may be configured topartially conform to the shape of a portion of the luer to facilitatesealing. In some embodiments the insert 102 is disposed within the cap100 such that the ridges 118, in threaded engagement with the luer, tendto align the cap 100 and the luer before the insert first end 104engages the luer. Thus, the cap 100 may be configured such that theinsert first end 104 is substantially perpendicular to the open end ofthe luer (not depicted) during coupling of the cap 100 and a luer. Insome embodiments insert reinforcements 106 are configured to align ormaintain the alignment of the insert first end 104 within (and withrespect to) the cap 100.

The insert 102 also comprises an insert body 108 between the insertfirst end 104 and an insert second end 110. In this embodiment theinsert second end 110 is configured to deform under axially appliedpressure. In this embodiment the insert first end 104 is reinforced withthe insert reinforcement 106 to reduce deformation of the insert firstend 104 and the insert body 108 under axially applied pressure. In thedepicted embodiment, the reservoir 112 comprises a reservoir hole 113through which the insert second end 110 and the insert body 108 may bepushed. The insert first end 104 further serves to limit the distancethe insert 102 can be pushed through the reservoir hole 113. The insertreinforcement 106 may in some embodiments be configured to further limitthe position the insert 102 takes within the reservoir 112.

FIG. 2A depicts an end view of another embodiment of a cap 200 thatresembles the cap 100 described above in certain respects. Accordingly,like features are designated with like reference numerals, with theleading digits incremented to “2.” For example, the embodiment depictedin FIGS. 2A-2B includes a cap body 220 that may, in some respects,resemble the cap body 120 of FIG. 1. Relevant disclosure set forth aboveregarding similarly identified features thus may not be repeatedhereafter. Moreover, specific features of the cap 200 and relatedcomponents shown in FIGS. 2A-2B may not be shown or identified by areference numeral in the drawings or specifically discussed in thewritten description that follows. However, such features may clearly bethe same, or substantially the same, as features depicted in otherembodiments and/or described with respect to such embodiments.Accordingly, the relevant descriptions of such features apply equally tothe features of the cap 200 and related components depicted in FIGS.2A-2B. Any suitable combination of the features, and variations of thesame, described with respect to the cap 100 and related componentsillustrated in FIG. 1 can be employed with the cap 200 and relatedcomponents of FIGS. 2A-2B, and vice versa. This pattern of disclosureapplies equally to further embodiments depicted in subsequent figuresand described hereafter, wherein the leading digits may be furtherincremented.

The cap 200 comprises the cap body 220 and a cap first end 216. The capfirst end 216 comprises a cap opening 214. The cap first end 216 isfurther configured to engage a male luer connector with threads 218. Aninsert first end 204 is visible through the cap opening 214. FIG. 2Aalso indicates plane A-A through which a cross-section of the cap 200 istaken and shown in FIG. 2B.

As noted above, FIG. 2B depicts a cross-section view of the cap 200through plane A-A of FIG. 2A. With reference to FIGS. 2A-2B, the cap 200illustrated therein comprises the cap first end 216, the cap body 220,and a cap second end 222. The cap first end 216 comprises protrusions218 which serve as threading to engage with a male luer connector. Thecap first end 216 further comprises the cap opening 214. The cap 200also comprises a cap chamber 224. In the illustrated embodiment, the capchamber 224 comprises an inner lumen which contains an insert 202 and areservoir 212. The insert 202 comprises the insert first end 204configured to engage with the open end of a medical connector. Theinsert 202 further comprises an insert body 208 and an insert second end210. The insert body 208 comprises an insert reinforcement 206 to reducedeformation of the insert 202 under axially applied pressure. The insertsecond end 210 is configured to deform under axially applied pressure.In this embodiment the insert second end 210 comprises two prongs whichwill bow outward radially until they come into contact with the capchamber's 224 inner walls.

FIGS. 3A and 3B depict two examples of medical connectors. FIG. 3Adepicts a perspective view of a medical connector hub 330. The hub 330has both a male luer connector 338 and two female luer connectors 332.The female luer connector 332 comprises a first end 336 and an opening334. The male luer connector 338 comprises a threaded engagement member342, a male luer connector body 340, and a male luer connector first end344. The male luer connector first end 344 comprises a male luer opening346. FIG. 3B depicts a medical connector 350 which comprises a femaleluer connector 352 with a first end 356. The female luer connector 352first end 356 comprises a first opening 354.

FIGS. 4A and 4B depict cross-section views of a cap 400 engaging a maleluer connector end 438, in first and second configurations,respectively. The medical connector such as the male luer connector end438 is inserted so that a male luer connector body 440 is inserted intoa cap opening 414. The end-user will slide the male luer connector body440 into the cap opening 414 until a male luer open end 444 comes intocontact with an insert first end 404. A male luer threaded engagementmember 442 slides around a cap first end 416 to begin to engage with capprotrusions 418 which serve as threading. An insert reinforcement 406and insert body 408 as well as a cap body 420 and cap second end 422 arealso indicated in the figures.

In the first configuration, shown in FIG. 4A, the end-user has not yetexerted enough axial force on an insert 402 to push it axially into acap chamber 424 enough to deform an insert second end 410. In the secondconfiguration, shown in FIG. 4B, the end-user has exerted enough axialforce on the insert 402 to deform the insert second end 410. The maleluer threaded engagement member 442 is thus in position to engage thethreading via the cap protrusions 418 and further tighten the cap 400onto the male luer connector end 438 which will exert additional axialforce on the insert 402. As the insert 402 is forced down into the capchamber 424 the insert second end 410 deforms, which may result in thedecrease of the cap chamber 424 available volume and the compression ofa reservoir 412. An antiseptic (not depicted) may then be forced out ofthe reservoir 412 (for example due to the decrease in the volume of thereservoir 412) into this remaining cap chamber 424 volume and would beexposed to the outer surface of the male luer open end 444 and the maleluer connector body 440. As the male luer connector end 438 is furthertightened onto the cap 400 it may be configured to limit the amount ofantiseptic which spills outside of the cap opening 414. In other words,the reservoir 412 may act like a sponge, absorbing antiseptic liquidwhen the reservoir 412 is uncompressed and releasing antiseptic liquidinto the cap chamber 424 as the reservoir 412 is compressed. Backing thecap 400 off the luer may allow the reservoir to return to anuncompressed configuration and reabsorb liquid antiseptic disposed inthe cap chamber 424.

FIG. 5 depicts a side view of a cap insert 502. The insert 502 comprisesan insert first end 504 configured and shaped to engage and seal orpartially seal a medical connector open end. The insert 502 furthercomprises a reinforcement 506 configured to reduce deformation of theinsert 502 near the insert first end 504. An insert second end 510 isconfigured to deform under axially applied pressure. The insert 502 ofFIG. 5 is shown in a generally uncompressed configuration.

FIG. 6 depicts a side view of a cap insert 602 shown after axiallyapplied pressure has deformed an insert second end 610. In other words,as compared to the uncompressed configuration of the insert 502 of FIG.5, FIG. 6 illustrates an analogous insert 602 in a compressedconfiguration. An insert first end 604 remains in its original shape andthus resists angular misalignment of the insert first end 604. Theinsert first end 604 is reinforced with an insert reinforcement 606. Inother embodiments the insert first end 604 resists deforming underaxially applied pressure while the insert second end 610 deforms becausethe insert first end 604 is made up of more rigid material than theinsert second end 610.

FIG. 7 depicts a perspective view of one embodiment of a reservoir 712.This embodiment of the reservoir 712 is a cube, and the reservoir 712comprises an opening 713 through which an insert, such as the insert502, may be placed.

FIG. 8A depicts a simplified exploded view of various components of amedical connector cap 800. The cap 800 has a cap first end 816 whichcomprises a cap opening 814 and a cap second end 822 configured to begrasped by an end-user. A cap body 820 is between the cap first end 816and the cap second end 822. In the illustrated embodiment, the cap firstend 816 is configured to be attached to a female luer connector andfurther comprises ridges 818 which serve as threads to engage the femaleluer connector. The cap 800 comprises an insert 802 and a reservoir 812.The insert 802 comprises an insert first end 804 configured to engageand seal or partially seal the open end of a female luer connector (notdepicted).

The insert first end 804 of the insert 802 may be dome shaped, with ahemispherical shape to engage and seal or partially seal the open end ofa female luer connector (not depicted). Additionally or alternatively,the insert first end 804 of the insert 802 may be configured topartially conform to the shape of a portion of the luer to facilitatesealing. In some embodiments the insert 802 is disposed within the cap800 such that the ridges 818, in threaded engagement with a luer, tendto align the insert 802 and the luer before the insert first end 804 ofthe insert 802 engages the open end of the luer. Additionally, in someembodiments the insert 802 comprises an insert second end 810 which isopen and configured to accept a reservoir such as the reservoir 812within the insert 802.

In some embodiments, the cap 800 is configured such that there is anannular gap 805 between the insert 802 and the cap 800 when the insert802 is unconstrained. This annular gap 805 may allow an antiseptic fluidto flow around the insert 802, for example, from the reservoir 812adjacent the insert second end 810 of the insert 802. Thus, the annulargap 805 may allow antiseptic fluid from the reservoir 812 to interactwith the insert first end 804 and then come into contact with the luerend (not depicted) during coupling of a luer and the cap 800. In someembodiments when the luer cap is partially or fully engaged with the cap800 a compressive force exerted on the insert 802 by the luer may causethe insert 802 to radially expand, thus reducing or closing the annulargap 805. This, in turn, may reduce or eliminate the antiseptic fluidflow around the insert 802, which may limit excess antiseptic fluid fromentering the luer end.

FIG. 8B depicts a side view of the cap 800. The cap 800 comprises thecap body 820 and the cap first end 816. The cap first end 816 comprisesan opening (not depicted). The cap first end 816 may be configured toengage a luer or other medical connector. The cap second end 822 may beconfigured to be grasped by an end-user. Line 8C of FIG. 8B indicatesthe plane of the cross-section depicted in FIG. 8C.

FIG. 8C depicts a cross-section of the cap 800. The cap body 820 and capfirst end 816 and indicated in this figure. In the illustratedembodiment, the cap first end 816 comprises the cap opening 814.Further, the ridges 818 within the cap opening 814 may be configured asthreads for engagement with a luer connector (not depicted).

As shown in FIG. 8C, the cap 800 may also comprise the cap chamber 824.The cap chamber 824 defines an inner lumen which contains the insert 802and the reservoir 812. Again, the first end 804 of the insert 802 ispositioned and configured to engage with the open end of a medicalconnector such as a luer when the cap 800 is coupled to a medicalconnector. The insert second end 810 of the insert 802 may be configuredto accommodate the reservoir 812 inside, or partially inside, the insert802. As noted above, the insert 802 and cap 800 may define the annulargap 805. In some embodiments an antiseptic fluid (not depicted) isdisposed within the cap chamber 824. The reservoir 812 may absorb someor all of the antiseptic fluid.

FIGS. 9A-9C depict a female luer connector 932 being connected to a capbody 920. FIG. 9A depicts a cross-section of the luer connector 932 witha female luer connector first end 936 comprising an opening 934. FIG. 9Bdepicts the cap body 920 engaging with the luer connector 932. A firstcap end 916 of the cap body 920 comprises an opening 914 into which theluer connector 932 can be engaged. Ridges 918 disposed within theopening 914 are configured as threads to engage the female luerconnector first end 936. In the illustrated embodiment, an insert 902has a dome shaped first end 904 which is configured to engage with thefemale luer connector first end 936. An annular gap 905 is disposedbetween the insert 902 and the cap body 920. The insert 902 may alsopartially receive and/or surround a reservoir 912. As further detailedin Example 1, below, FIGS. 9A-9B also depict the deposition of atungsten powder 970 on an inner luminal surface 935 of the female luerconnector first end 936 and around the circumference of the opening 934.

FIG. 9C depicts a cross-section of the female luer connector first end936 after it has been disengaged from a cap 900, according to theprocedure outlined in Example 1. As compared to the connector asdepicted in FIGS. 9A-9B, the tungsten powder 970 generally remains onthe inner luminal surface 935 after disengagement of the female luerconnector first end 936 from the cap 900. As illustrated in FIG. 9C, insome instances the tungsten powder 970 may be displaced by the first end904 of the insert 902 when coupled as shown in FIG. 9B. As explained inExample 1, the position of the tungsten powder 970 in FIG. 9Cillustrates how the insert 902 and reservoir 912 may limit ingress ofantiseptic fluid into the female luer connector first end 936.

Kits that include a medical connector cap are also within the scope ofthis disclosure. For example, a kit may include any of the devicesdescribed above. The kit may also include other elements, such asinstructions for using the devices. Kits may additionally oralternatively include (1) male luer connector caps; (2) female luerconnector caps; (3) double-ended luer connector caps; (4) sterilegloves; (5) sterile barrier; (6) antiseptic swabs; and (7) sterilegauze, among other potential elements.

Any methods disclosed herein include one or more steps or actions forperforming the described method. The method steps and/or actions may beinterchanged with one another. In other words, unless a specific orderof steps or actions is required for proper operation of the embodiment,the order and/or use of specific steps and/or actions may be modified.Moreover, sub-routines or only a portion of a method described hereinmay be a separate method within the scope of this disclosure. Statedotherwise, some methods may include only a portion of the stepsdescribed in a more detailed method.

Reference throughout this specification to “an embodiment” or “theembodiment” means that a particular feature, structure, orcharacteristic described in connection with that embodiment is includedin at least one embodiment. Thus, the quoted phrases, or variationsthereof, as recited throughout this specification are not necessarilyall referring to the same embodiment.

Similarly, it should be appreciated by one of skill in the art with thebenefit of this disclosure that in the above description of embodiments,various features are sometimes grouped together in a single embodiment,figure, or description thereof for the purpose of streamlining thedisclosure. This method of disclosure, however, is not to be interpretedas reflecting an intention that any claim requires more features thanthose expressly recited in that claim. Rather, as the following claimsreflect, inventive aspects lie in a combination of fewer than allfeatures of any single foregoing disclosed embodiment. Thus, the claimsfollowing this Detailed Description are hereby expressly incorporatedinto this Detailed Description, with each claim standing on its own as aseparate embodiment. This disclosure includes all permutations of theindependent claims with their dependent claims.

Recitation in the claims of the term “first” with respect to a featureor element does not necessarily imply the existence of a second oradditional such feature or element. It will be apparent to those havingskill in the art that changes may be made to the details of theabove-described embodiments without departing from the underlyingprinciples of the present disclosure.

While the disclosure is susceptible to various modifications andimplementation in alternative forms, specific embodiments have beenshown by way of non-limiting example in the drawings and have beendescribed in detail herein. However, it should be understood that thedisclosure is not intended to be limited to the particular formsdisclosed. Rather, the disclosure includes all modifications,equivalents, and alternatives falling within the scope of the disclosureas defined by the following appended claims and their legal equivalents.

Without further elaboration, it is believed that one skilled in the artcan use the preceding description to utilize the present disclosure toits fullest extent. The examples and embodiments disclosed herein are tobe construed as merely illustrative and exemplary and not a limitationof the scope of the present disclosure in any way. It will be apparentto those having skill in the art, and having the benefit of thisdisclosure, that changes may be made to the details of theabove-described embodiments without departing from the underlyingprinciples of the disclosure herein.

EXAMPLE 1

Disinfecting caps for open female connectors were tested with stopcockconnectors to observe alcohol ingress into the lumen of the stopcockconnector. Testing did not show alcohol ingress but reflected evidenceof the insert protruding for up to 1 mm into the lumen of the connector.As discussed above, FIGS. 9A-9C schematically illustrate the componentsof this Example. Three luer connector/cap assemblies were tested. Forthis example, the inserts 902 were made from Santoprene 8281-55MED. Thereservoir 912 was composed of polyester urethane foam measuring 0.2inches in diameter and having a height of 0.3 inches. 175 μl of 70%isopropyl alcohol was dispensed into the cap 900, and the insert902/reservoir 912 assembly was inserted into the cap 900. The resultingassembly was analogous to the assembly of the embodiment shown in FIG.8C.

A layer of the tungsten powder 970 was dusted into the inner luminalsurface 935 of the luer connector 932 to act as the contrast agent, asthe tungsten powder 970 would get disrupted when it encountered alcoholduring testing of coupling and uncoupling of the luer connector 932 andthe cap 900.

Luer connectors 932 dusted with a tungsten powder 970 (in theconfiguration shown in FIG. 9A) were mounted onto a luer post and placedin a 3D CT scanner for imaging. The luer connectors 932 were thenassembled with the caps 900 as shown in FIG. 9B and exposed to x-rayswhich was then followed by disassembly and a last round of imaging.

The caps 900 were found to maintain contact with the opening 934 of theluer connector 932 as the insert 902 in the cap 900 deformed to maintainpressure at the insert 902—the opening 934 interface. This sealprevented alcohol from contact with the inner luminal surface 935 of theluer connector 932. Tungsten particles were observed to be displaced (asshown in FIG. 9C) around the circumference of the opening 934. Thisdisplacement can be attributed to the physical disturbance caused by theinsert 902 that protruding into luer connector 932 to prevent alcoholingress.

We claim:
 1. A cap for a medical connector, the cap comprising: a firstend comprising a first opening configured to connect a medicalconnector; a chamber disposed in the cap; a reservoir disposed at leastpartially within the chamber; and an insert disposed at least partiallyin the chamber, the insert comprising a dome shaped first end and asecond end configured to deform during use.
 2. The cap of claim 1,wherein the first opening comprises threads configured to connect to aluer connector and wherein the threads comprise a hard stop to preventthe end-user from over rotating the cap.
 3. The cap of claim 2, whereinthe chamber contains a disinfectant.
 4. The cap of claim 3, wherein thedisinfectant is an antiseptic fluid.
 5. The cap of claim 4, wherein theantiseptic fluid is selected from the group consisting of: isopropylalcohol, hydrogen peroxide, chlorhexidine gluconate, iodophor, andpovidone iodine.
 6. The cap of claim 3, wherein the disinfectant isselected from the group consisting of: disinfectant beads, disinfectantfoam, and disinfectant loaded polymer.
 7. The cap of claim 6, whereinthe disinfectant beads are hydrogel beads.
 8. The cap of claim 1,wherein the reservoir is absorbent.
 9. The cap of claim 1, wherein thereservoir is a polyester urethane foam.
 10. The cap of claim 4, whereinthe insert first end is configured to limit fluid flow into a connectorlumen when the insert first end is in contact with the a connector; andwherein the insert first end is reinforced to limit deformation of theinsert first end.
 11. The cap of claim 3, wherein the reservoir iscompressed when the insert second end deforms.
 12. The cap of claim 11,wherein the reservoir expands and tends to absorb the disinfectant inthe reservoir when a connector is disconnected from the first openingand the insert second end assumes at least a portion of its originalshape to maintaining a partial seal on the open end of the connectorwhile the connector is being disconnected.
 13. The cap of claim 11, thechamber further comprising a first closed compartment containing thedisinfectant, the closed compartment configured to open and release thedisinfectant when the insert second end deforms.
 14. A method of cappinga medical connector, the method comprising: connecting a cap to and openend of a medical connector; contacting a first end of an insert disposedwithin the cap with the medical connector; deforming a second end of theinsert such that the second end of the insert provides a force tomaintain contact between the first end of the insert and the medicalconnector; and disinfecting the open end of the medical connector whileminimizing introduction of disinfectant inside the open end of themedical connector.
 15. The method according to claim 14, wherein the capcomprises threads configured to prevent an end-user from over rotatingthe cap.
 16. The method according to claim 14, wherein the disinfectantis an antiseptic fluid.
 17. The method according to claim 14, whereinthe disinfectant is selected from the group consisting of: disinfectantbeads, disinfectant foam, and disinfectant loaded polymer.
 18. Themethod according to claim 14, further comprising compressing anabsorbent reservoir within the cap to release antiseptic fluid.
 19. Themethod according to claim 18, wherein the reservoir is a polyesterurethane foam.
 20. The method according to claim 18, further comprisingabsorbing a portion of the antiseptic fluid in the reservoir byuncompressing the reservoir.